Table 2.

Clinical and Microbiologic Outcomes for Oritavancin-Treated Patients in the CHROME Registry and SOLO Clinical Program

Outcome	CHROME (n = 112), % (n/N)	Pooled SOLO (n = 978), % (n/N)
Clinical successa	92.8 (103/111)	92.6 (760/821)b
Clinical failure	7.2 (8/111)	7.4 (61/821)
Post-therapy microbiologic assessment in 30 patientsc		Not available; clinical response by pathogen at defined end points
Microbiologic eradication	90.0 (27/30)
Microbiologic persistence	10.0 (3/30)

Abbreviation: CHROME, Clinical and Historic Registry and Orbactiv Medical Evaluation.

^aClinical success in the SOLO study (CE population at post-therapy follow-up) was defined as investigator-assessed clinical success at post-therapy evaluation at days 14 to 24 (7 to 14 days from end of blinded therapy). A patient was categorized as a clinical success if the patient experienced a complete or nearly complete resolution of baseline signs and symptoms related to primary ABSSSI site such that no further treatment with antibiotics was needed. CHROME definitions excluded the need for additional antibiotics. Clinical success includes clinical cure and clinical improvement, as assessed within 28 days following oritavancin administration.

^bReference 3. Clinically evaluable population at post-therapy follow-up as defined above.

^cIn CHROME, microbiologic assessment includes laboratory-confirmed microbial eradication of the same baseline pathogen at the site of the initial infection or microbiologically confirmed persistence.